EEA TRIEEA31MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10884521593046), received between Sep 25, 2018 and Aug 26, 2026 — classified as 2 deaths, 77 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (54 reports).

1 other recall cover devices cleared under the same FDA submission (K172361, K221005); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Mechanics Altered

  According to the reporter, during a low anterior resection, the circular stapler cut without stapling. A new circular stapler was used to resolve the issue. Due to the issue, the patient extended the hospital stay for two more days and the patient had an antibiotic while there was an abscess at the site of the stapler due to stool observation after the stapler failure.

  Patient problems: Abscess; Failure to Anastomose

  MAUDE report 50459043 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DISCOID RESECTION OF A NODULE IN THE RECTOSIGMOID AREA USING A CIRCULAR STAPLER, THE SURGEON INSERTED THE STAPLER WITH THE ANVIL INSTALLED AND CLOSED, THEN OPENED AND CLOSED IT AGAIN TO TAKE TISSUE. THE ANVIL WAS NOT SEEN IN THE CORRECT POSITION, AND WHEN THE SURGEON OPENED THE DEVICE AGAIN, THE ANVIL FELL DOWN AND STAPLING COULD NOT BE COMPLETED. THE PROCEDURE WAS EXTENDED BY 15 MINUTES. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249827 ↗
• MalfunctionMay 6, 2026Break; Mechanics Altered

  IT WAS REPORTED THAT DURING A SURGERY, INCREASED RESISTANCE WAS FELT WHEN FIRING. THE INSTRUMENT DID NOT FIRE AND NO STAPLES WERE EJECTED. UPON INSPECTION OUTSIDE THE CAVITY, THE SURGEON CONFIRMED THAT THERE WAS A BREAK IN THE FOLDING STEM; IT WOULD NOT STAY IN PLACE AND HAD A CRACK. THE DEVICE WAS REPLACED WITH ANOTHER CIRCULAR STAPLER DURING THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090216 ↗
• MalfunctionFeb 19, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A ROBOTIC LOW ANTERIOR RESECTION, THE PRODUCT CUT TISSUE DURING THE CLOSING PROCESS BUT DID NOT STAPLE. THE DEVICE DID NOT FIRE A SINGLE STAPLE. THE ANASTOMOSIS COULD NOT BE COMPLETED AS INTENDED. THE TISSUE WAS STITCHED TOGETHER WITH SUTURES TO STOP THE BLEEDING AND REINFORCE THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24386755 ↗
• MalfunctionFeb 16, 2026Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT INTRAOPERATIVELY, STAPLES WERE FIRED, BUT THERE WAS NO EVIDENCE OF STAPLES IN THE ANTERIOR WALL OF THE ANASTOMOSIS. DEHISCENCE WAS OBSERVED.

  Patient problems: Failure to Anastomose; Organ Dehiscence

  MAUDE report 24357230 ↗
• MalfunctionFeb 12, 2026Failure to Align

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SETTING UP THE INSTRUMENT PRIOR TO USE ON THE PATIENT, THE ANVIL WAS FOUND TO BE TILTED BEFORE FIRING AND PUTTING IT ON PATIENT. THE ISSUE WAS RESOLVED BY USING ANOTHER STAPLER FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327143 ↗
• MalfunctionFeb 10, 2026Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, WHILE ON ANTERIOR RESECTION, THE ANVIL ASSEMBLY LEG OF THE CIRCULAR STAPLER WAS BENT AND THE ANVIL TILTED PRIOR TO FIRING. THE DEVICE WAS REPLACED WITH A NEW CIRCULAR STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309524 ↗
• InjuryFeb 5, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE USING THE CIRCULAR STAPLER, THE DEVICE CUT TISSUE BUT DID NOT STAPLE IT, RESULTING IN A PROCEDURAL ISSUE THAT REQUIRED CONVERSION TO OPEN SURGERY. THE PATIENT EXPERIENCED EXTENDED HOSPITALIZATION.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 24271543 ↗
• MalfunctionFeb 2, 2026Misfire; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE END-TO-END ANASTOMOSIS IN A BLADDER FISTULA PROCEDURE, WHEN THE STAPLER WAS REMOVED AFTER FIRING, THE STAPLER WENT OUT WITHOUT THE ANVIL. THE ANVIL HAD DISENGAGED AND FELL INTO THE CAVITY. THE DONUTS WERE ALSO INCOMPLETE. ONE OF THE DONUTS WAS ATTACHED TO THE ANVIL AND THE OTHER TO THE STAPLER. STAPLES WERE VISIBLE ON THE DONUTS, BUT THE STAPLE LINE WAS INCOMPLETE. THE ANVIL THAT HAD REMAINED IN THE INTESTINE WAS REMOVED. BOTH PARTS OF THE INTESTINE WERE RESECTED AGAIN IN ORDER TO PERFORM THE END-TO-END ANASTOMOSIS AGAIN WITH A NEW STAPLER.  THE PROCEDURE WAS EXTENDED FOR APPROXIMATELY 45 MINUTES DUE TO ETH ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24235249 ↗
• MalfunctionDec 26, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A COLON CANCER PROCEDURE, THERE WERE UNKNOWN FIRING ISSUES. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898547 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 48 HOURS POST-OPERATIVELY OF RECTOSIGMOIDECTOMY, WHEN APPLIED ON RECTAL ANASTOMOSIS, THERE WAS FISTULA IN THE STAPLE LINE. THE PATIENT WAS REOPERATED AND REQUIRED A TEMPORARY COLOSTOMY BAG.

  Patient problems: Fistula; Tissue Breakdown

  MAUDE report 23671181 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 48 HOURS AFTER A PROCEDURE, THERE WAS A FISTULA AT THE STAPLE LINE. ADDITIONAL SURGERY WAS PERFORMED, AND THE PATIENT HAS A COLOSTOMY BAG TO RESOLVE THE ISSUE.

  Patient problems: Fistula; Tissue Breakdown

  MAUDE report 23657214 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LOWER ANTERIOR RESECTION (LAR) POST-OPERATIVE FOLLOW-UP CHECKUP, THE PATIENT REPORTED OF HAVING CONSTIPATION TWO WEEKS PRIOR. THE SURGEON THEN INSPECTED THAT THE CIRCULAR STAPLER ANASTOMOTIC SITE HAD SOME LEAKING. MEDICATIONS WERE REQUIRED FOR TREATMENT. THE PATIENT HAD TEMPORARY STOMA AND AN ENDOSCOPIC SPONGE WAS USED. CURRENTLY, THE PATIENT IS DOING WELL.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23568294 ↗
• MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN SIGMOID COLON PROCEDURE, SPECIFICALLY AT THE ANASTOMOSIS STEP, THERE WAS A STAPLE FORMATION ISSUE. THE PROCEDURE WAS EXTENDED BY 30 MINUTES AS A RESULT. THE DEVICE WAS REPLACED BY COMPETITORS DEVICE.

  Patient problems: Failure to Anastomose

  MAUDE report 23523783 ↗
• MalfunctionNov 11, 2025Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING AN ENDOMETRIOSIS DISCOID RESECTION, PRIOR TO FIRING, THE SURGEON OPENED THE ANVIL, AND THE LATTER CLOSED AND WHEN THE SURGEON WANTED TO COVER IT, THE ANVIL FLIPPED OVER. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THEREWAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519472 ↗
• InjuryNov 6, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE RECTUM RESECTION, THE ANVIL BECAME STUCK TO THE SURROUNDING TISSUE. IT WAS ALSO NOTED THAT THE THE ANVIL DID NOT TILT AFTER FIRING. THE SURGEON STAPLED AGAIN WITH A DIFFERENT CIRCULAR STAPLER FROM A DIFFERENT LOT AND THE ANVIL GOT STUCK AGAIN, AT WHICH POINT THE SURGEON MADE A TEMPORARY COLOSTOMY BAG AS AN INTERVENTION. ADDITIONAL RESECTION AND RE-STAPLING WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Laceration(s); Tissue Breakdown

  MAUDE report 23492978 ↗
• InjuryNov 6, 2025Difficult to Remove; Difficult to Remove

  PLI 10 AND PLI 20 - IT WAS REPORTED THAT DURING THE RECTUM RESECTION, IN BOTH ANASTOMOSIS ATTEMPTS WITH TWO CIRCULAR STAPLER, THE PROXIMAL HEAD WAS STUCK AND DID NOT DISCONNECT FROM THE COLICAL STUMP, CREATING A CONTINUOUS OPENING ON THE ANASTOMOSIS WHICH REQUIRED RESECTION AND RE-SEWING OF THE ANASTOMOSIS ON THE FIRST ATTEMPT AND, ON THE SECOND ATTEMPT, FOR A LARGER LONGITUDINAL CONTINUOUS OPENING OF THE RECTUM. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. IT WAS NECESSARY TO PROCEED WITH A FURTHER RESECTION WITH SINKING OF THE RECTAL STUMP AND SIMULTANEOUS CREATION OF A TEMPORARY COLOSTOMY. NO FURTHER ATTEMPTS WERE MADE TO CONSTRUCT THE ANASTOMOSIS IN ORDER TO PREVENT FUTURE POTENTIAL RECTAL TISSUE RECANALIZATION.

  Patient problems: Failure to Anastomose; Laceration(s); Tissue Breakdown

  MAUDE report 23492954 ↗
• MalfunctionNov 6, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT PREOPERATIVELY, THE ANVIL WAS FOUND TILTED WHEN OPENED DURING PREPARATION. THE NURSE SEALED THE PRODUCT AND USED ANOTHER PRODUCT INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487454 ↗
• MalfunctionSep 16, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CIRCULAR STAPLER, THE ANVIL TILTED BEFORE FIRING. THE DOCTOR CLOSED THE STAPLER AND THEN OPENED IT TO REPOSITION, AT WHICH POINT THE ANVIL TILTED AND WOULD NOT RETURN TO NORMAL. ANOTHER CIRCULAR STAPLER WAS OPENED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062614 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE PACKAGE OF THE CIRCULAR STAPLER, CERTAIN COMPONENTS WERE DISENGAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925940 ↗
• MalfunctionAug 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ENDOMETRIOSIS PROCEDURE, AFTER FIRING THE STAPLER, THE ANVIL DID NOT BEND AFTER FIRING. THE SURGEON REPLACED THE DEVICE AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898823 ↗
• MalfunctionAug 18, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS POOR STAPLE FORMATION. THE STAPLES DID NOT CLOSE IN THE ANTERIOR PART OF THE STAPLING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED TO REDO THE ANASTOMOSIS TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR TWO HOURS AS A RESULT.

  Patient problems: Failure to Anastomose

  MAUDE report 22834418 ↗
• MalfunctionAug 18, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRAOPERATIVELY, AFTER FIRING THE CIRCULAR STAPLER, THE ANVIL DETACHED FROM THE STAPLER WHEN REMOVING IT FROM THE CAVITY. THE SURGEON NOTED THAT THERE WAS TENSION WHEN REMOVING THE STAPLER FROM THE CAVITY. THE SURGEON MANUALLY CLAMPED AND REMOVED THE ANVIL FROM THE PATIENT CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829921 ↗
• MalfunctionAug 14, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE; THERE WERE PRESENCE OF MALFORMED STAPLES. THE SURGEON HAD TO PERFORM A LEAK TEST A COUPLE OF TIMES AND LEAKAGE WAS OBSERVED. TO ADDRESS THE ISSUE, THE STAPLE LINE WAS REINFORCED WITH SUTURES SPECIFICALLY AROUND THE AREA WHERE THE STAPLES WERE FOUND TO BE DEFECTIVE. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 30 MINUTES AS A RESULT.

  Patient problems: Failure to Anastomose

  MAUDE report 22810637 ↗
• MalfunctionJul 11, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THE USE OF THE CIRCULAR STAPLER, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE CAVITY. THE HEAD OF THE DEVICE BECAME STUCK IN THE RECTUM AND HAD TO BE REMOVED SEPARATELY AFTER BEING DISCONNECTED FROM THE INSTRUMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487282 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172361, K221005. One submission often covers many models, so check the product and lot details in each record.

• Z-0070-2019 · Aug 17, 2018 · Terminated
  EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a